NFLD Northfield Laboratories Inc. (MM)

Northfield Laboratories (NASDAQ: NFLD) released the following statement today in response to news reports that Senator Grassley of Iowa has raised questions about the Northfield trauma trial research protocol: Northfield is confident that the study is being conducted with the utmost concern for patient safety and in accordance with all applicable regulations. Northfield has communicated with FDA, and the status of Company's Pivotal Phase III trial remains unchanged and will continue. On four occasions, after 60, 120, 250, and 500 patients had been enrolled and followed for 30 days, the Independent Data Monitoring Committee (IDMC) responsible for overseeing this study thoroughly reviewed all safety data. On all four occasions, the IDMC recommended that the study continue without modification. On February 23, 2006, the IDMC reiterated its findings and its recommendation that the trial continue to completion: "As has been reported to Northfield Laboratories regarding the final assessment of the interim data, including 500 randomized patients, there were no statistically significant trends or safety issues identified to warrant modification or other changes in the current protocol and patient recruitment. The IDMC conclusion is that completion of the trial is appropriate with completion of datasets and final analysis indicated." Northfield intends to cooperate fully with any review of Finance Committee. The Company continues to believe that PolyHeme has the potential to fundamentally improve the early treatment of injured patients, whether trauma victims at home or combat casualties on the battlefield. About Northfield Laboratories Northfield Laboratories Inc. is a leader in developing an oxygen-carrying resuscitative fluid, PolyHeme(R), for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings. PolyHeme(R) is a solution of chemically modified human hemoglobin that requires no cross matching and is therefore compatible with all blood types. It has a shelf life in excess of 12 months. Enrollment is currently underway in a pivotal Phase III trial of PolyHeme(R) beginning in the pre-hospital setting. For further information, visit www.northfieldlabs.com. This press release may contain forward-looking statements concerning, among other things, Northfield's future business plans and strategies and clinical and regulatory developments affecting our PolyHeme(R) red blood cell substitute product. These forward-looking statements are identified by the use of such terms as "intends," "expects," "plans," "estimates," "anticipates," "should," "believes" and similar terms. These forward-looking statements involve inherent risks and uncertainties. Our actual results may therefore differ materially from those predicted by the forward-looking statements because of various factors and possible events, including our ability to obtain FDA approval to market PolyHeme commercially, the availability of capital to finance our clinical trials and ongoing business operations, our ability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our ability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our ability to protect our intellectual property rights, the possibility that we may be subject to product liability claims and other legal actions, our dependency on a limited number of key personnel, the uncertainty of third party reimbursement for our product and other risks and uncertainties described from time to time in our periodic reports filed with the Securities and Exchange Commission, including our most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. These forward-looking statements speak only as of the date of this press release. We do not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the time such statement is made. All subsequent written and oral forward-looking statements attributable to Northfield or any person acting on our behalf are qualified by this cautionary statement.